MyopiaNCT05888792
Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes
A study testing Variant of Defocus Incorporated Spectacle lens (DG2) in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The purpose of this study is to examine the efficacy and performance of the variant of Defocus Incorporated Spectacle lenses on controlling myopia progression in fast progressing myopic children. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Variant of Defocus Incorporated Spectacle lens (DG2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Jul 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- SER: -0.75D or below in both eyes
- Documented history of fast progressing myopia, either in SER or AL
- SER progression: 0.50D/year or more
- AL elongation: 0.27mm/year or more
- For children aged 4-6 years without past prescription forms,
- 4-5 years old: myopia of -0.75D or below in both eyes
Show all 13Show fewer
- 6 years old: myopia of -1.25D or below in at least one eye, with the other eye -0.75D or below
- Best-corrected visual acuity (VA) in both eyes:
- 4 - 6 years old: 0.20 logMAR (or its equivalent) or better
- 7-12 years old: 0.00 logMAR (or its equivalent) or better
- Acceptance of random group allocation and the masked study design
- Anisometropia of 1.50 D or less
- Astigmatism of 2.00 D or less
Who cannot join
- Strabismus and binocular vision abnormalities
- Ocular and systemic abnormalities
- Prior experience of myopia control
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Optometry, The Hong Kong Polytechnic University
Hung Hom
About this study
Official title: Myopia Control Effectiveness of Second-generation Defocus Incorporated Multiple Segments Spectacle Lenses on Fast Progressing Myopes: A Randomized Controlled Trial
The purpose of this study is to examine the efficacy and performance of the variant of Defocus Incorporated Spectacle lenses on controlling myopia progression in fast progressing myopic children.
Read the detailed description
The variant of Defocus Incorporated Spectacle lenses (D2) is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.
Participants will be randomly allocated to either single vision lens group (control) or the variant of Defocus Incorporated Spectacle lens (D2) group (treatment). After 12 months of lens wear, the SV lens prescribed to the control group will be replaced with the D2 lens and be monitored for another 36 months. In parallel, the D2 treatment groups will continue their corresponding intervention for another 36 months. Their cycloplegic refraction and axial length will be monitored every 6 months over 4 years. The changes in refractive errors and axial length in two groups will be compared.
- Conditions
- Myopia
- Being tested
- Variant of Defocus Incorporated Spectacle lens (DG2)
- Keywords
- Myopia, Defocus
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variant of Defocus Incorporated Spectacle lens (DG2)Other
DG2 is a variant of Defocus Incorporated Spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously
| Study group | Role | What they receive |
|---|---|---|
| Single vision lens group | No intervention | Subjects in single vision lens group will receive a pair of single vision lenses for the first year of study. They will then receive a pair of DG2 lenses for an additional 3 years. |
| D2 lens group | Experimental | Subjects in D2 lens group will receive a pair of D2 lenses over the 4-year study. Receives: Other: Variant of Defocus Incorporated Spectacle lens (DG2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic refraction change in spherical equivalent refraction (SER)
Cycloplegic SER (in diopter) will be measured using an open field autorefractor.
Change in SER with cycloplegia from the baseline every 6 months for 4 years over the study period.
Measured: Baseline, every 6 months for 4 years
Secondary outcomes (1)
Axial length change
Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer.
Change in axial length from the baseline every 6 months for 4 years over the study period.
Measured: Baseline, every 6 months for 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start29 Jul 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly allocated to either control (wearing single vision lenses) group or treatment (D2 lens) group for first 12 months. After 12 months, the SV lens prescribed to the control group will be replaced with the D2 lens and be monitored for another 36 months. In parallel, the D2 treatment groups will continue their corresponding intervention for 36 months.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- HOYA Lens Thailand LTD.
- Responsible party
- Sponsor
- Investigators
- Dennis Yan Yin Tse, PhD, Principal investigator, School of Optometry, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888792
- Sponsor's protocol ID
- H-ZGET
- Status last verified
- Apr 2026
- First submitted
- 24 May 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hon Y, Chun RKM, Leung TW, Qi H, Hasegawa K, Leung KY, To CH, Lam CSY, Tse DY. Myopia control efficacy of second-generation defocus incorporated multiple segments spectacle lenses on fast progressing myopes: Study protocol of a randomised controlled trial. PLoS One. 2025 Oct 31;20(10):e0335061. doi: 10.1371/journal.pone.0335061. eCollection 2025.
PubMed 41171741
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Control Effectiveness of Second-generation Defocus Incorporated Multiple Segments Spectacle Lenses on Fast Progressing Myopes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05888792
- Acronym / sponsor ID
- H-ZGET
- Conditions
- Myopia
- Keywords
- Myopia, Defocus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- HOYA Lens Thailand LTD.
- Study start
- 29 Jul 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the efficacy and performance of the variant of Defocus Incorporated Spectacle lenses on controlling myopia progression in fast progressing myopic children.
Detailed description
The variant of Defocus Incorporated Spectacle lenses (D2) is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.
Participants will be randomly allocated to either single vision lens group (control) or the variant of Defocus Incorporated Spectacle lens (D2) group (treatment). After 12 months of lens wear, the SV lens prescribed to the control group will be replaced with the D2 lens and be monitored for another 36 months. In parallel, the D2 treatment groups will continue their corresponding intervention for another 36 months. Their cycloplegic refraction and axial length will be monitored every 6 months over 4 years. The changes in refractive errors and axial length in two groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to either control (wearing single vision lenses) group or treatment (D2 lens) group for first 12 months. After 12 months, the SV lens prescribed to the control group will be replaced with the D2 lens and be monitored for another 36 months. In parallel, the D2 treatment groups will continue their corresponding intervention for 36 months.
| Arm | Type | Receives |
|---|---|---|
| Single vision lens group | No intervention | –Subjects in single vision lens group will receive a pair of single vision lenses for the first year of study. They will then receive a pair of DG2 lenses for an additional 3 years. |
| D2 lens group | Experimental | Other: Variant of Defocus Incorporated Spectacle lens (DG2)Subjects in D2 lens group will receive a pair of D2 lenses over the 4-year study. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- SER: -0.75D or below in both eyes
- Documented history of fast progressing myopia, either in SER or AL
- Best-corrected visual acuity (VA) in both eyes:
- Acceptance of random group allocation and the masked study design
- Anisometropia of 1.50 D or less
Key exclusion criteria (3 listed)
- Strabismus and binocular vision abnormalities
- Ocular and systemic abnormalities
- Prior experience of myopia control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Variant of Defocus Incorporated Spectacle lens (DG2)DG2 is a variant of Defocus Incorporated Spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously | Other | D2 lens group |
Primary outcome
Cycloplegic refraction change in spherical equivalent refraction (SER)
Time frame: Baseline, every 6 months for 4 years
Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline every 6 months for 4 years over the study period.
1 secondary outcome
Axial length change
Time frame: Baseline, every 6 months for 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 41171741Hon Y, Chun RKM, Leung TW, Qi H, Hasegawa K, Leung KY, To CH, Lam CSY, Tse DY. Myopia control efficacy of second-generation defocus incorporated multiple segments spectacle lenses on fast progressing myopes: Study protocol of a randomised controlled trial. PLoS One. 2025 Oct 31;20(10):e0335061. doi: 10.1371/journal.pone.0335061. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Yan Yin Tse, PhD principal investigator
School of Optometry, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variant of Defocus Incorporated Spectacle lens (DG2) in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycloplegic refraction change in spherical equivalent refraction (SER) (time frame: Baseline, every 6 months for 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05888792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.